A Clinical Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05483660

Collaborator

(none)

300

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and efficacy of Lactobacillus plantarum, Bacillus coagulans and Lactobacillus plantarum + Bacillus coagulans for eradication of Helicobacter Pylori, as well as the efficacy of Lactobacillus plantarum and Bacillus coagulans on side-effect caused by Helicobacter Pylori.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Other: Lactobacillus plantarum Other: Bacillus coagulans Other: Lactobacillus plantarum + Bacillus coagulans Other: Placebo	Phase 2

Detailed Description

All patients included in this randomized controlled clinical trial will be selected according to strict inclusion and exclusion criteria. At the same time, the benefits and risks of participating in this trial will be explained to the patients before the start of the study, the patients' right to informed consent will be respected, and the informed consent will be signed. After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participants and investigator) in a 1:1:1:1 ratio to Lactobacillus plantarum (1.5×10^{10 per time, three times daily) or Bacillus coagulans (1.5×10}10 per time, three times daily) or Lactobacillus plantarum + Bacillus coagulans (1.5×10^10 per time, three times daily) or placebo ( 15g per time, three times daily). At the same time, volunteers will be recruited from healthy people to perform the same treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

The person in charge of assigning patients to treatment groups does not know which treatments the patients receive, so they do not select patients in order of their own volition. Patients themselves do not know what treatment they are receiving, so they do not change their compliance or reporting of symptoms.

Primary Purpose:

Treatment

Official Title:

A Randomized, Controlled, Double-blind Trial on the Efficacy of Gastric Probiotics in the Treatment of Helicobacter Pylori Infection

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lactobacillus plantarum 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.	Other: Lactobacillus plantarum 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Experimental: Bacillus coagulans 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.	Other: Bacillus coagulans 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Experimental: Lactobacillus plantarum + Bacillus coagulans 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.	Other: Lactobacillus plantarum + Bacillus coagulans 1.5×10^10 CFU probiotics and adult milk powder 15g per time , three times daily and half an hour before meal.
Placebo Comparator: Placebo Adult milk powder 15 g per time, three times daily and half an hour before meal.	Other: Placebo Adult milk powder 15 g pertime, three times daily and half an hour before meal.

Outcome Measures

Primary Outcome Measures

Eradication of Helicobacter pylori [The eighth week of the trial]
All participants will have a 13C-urea breath test to see if their 13C value falls below the threshold for H. pylori eradication.

Secondary Outcome Measures

The condition of gastrointestinal symptoms before the trial [Baseline]
We will use Gastrointestinal symptoms rating scale (GSRS) to know about the baseline level of their gastrointestinal symptoms before they receive the probiotic or placebo.
The condition of gastrointestinal symptoms in the first week [The first week of the trial.]
We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms after they receive the probiotic or placebo already a week.
The condition of gastrointestinal symptoms in the second week [The second week of the trial.]
We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms after they receive the probiotic or placebo after two weeks.
The condition of gastrointestinal symptoms in the third week [The third week of the trial.]
We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms after they receive the probiotic or placebo after three weeks.
The condition of gastrointestinal symptoms in the fourth week [The fourth week of the trial.]
We will use Gastrointestinal symptoms rating scale (GSRS) to know about the level of their gastrointestinal symptoms at the fourth week of this trial.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Aged 18-75 years.
Diagnosed by 13C-UBT within 2 weeks before entry.

Exclusion Criteria:

Previous treatment for H. pylori infection.
Administration of antibiotics, probiotics/prebiotics, PPIs, H2 receptor antagonists, bismuth preparations, laxatives, anti-diarrhoeals, and certain antimicrobial traditional Chinese medicines 4 weeks before.
Previous history of gastrointestinal surgery.
Severe or unstable diseases.
Pregnancy or lactation.
Alcoholics and drug abusers.
Staff of this trial.